Glenmark gets CDSCO panel nod to manufacture and market COPD drug
New Delhi: Based on the justification provided by the pharmaceutical major Glenmark pharmaceuticals, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to manufacture and market the fixed dose combination (FDC) drug containing Indacaterol (as acetate) and Mometasone furoate Dry Powder for Inhalation (DPI) in Capsules.
However, this approval is subject to the condition that the firm should conduct active post marketing surveillance for which protocol should be submitted to CDSCO within three months of approval of the drug
This came in line with the proposal presented by the drug maker Glenmark pharmaceuticals along with the justification of BA study waiver and in vitro drug deposition study, published data, and results of global clinical trial (GCT) of the F.D.C conducted by the other firm in which India was one of the participating countries before the committee.
As per the study, Indacaterol acetate/mometasone furoate provides sustained improvements in lung function compared with salmeterol xinafoate/fluticasone propionate in patients with moderate-to-very-severe Chronic obstructive pulmonary disease (COPD).
Chronic obstructive pulmonary disease includes chronic bronchitis, in which the bronchi (large air passages) are inflamed and scarred, and emphysema, in which the alveoli (tiny air sacs) are damaged. It develops over many years and is usually caused by cigarette smoking.
Indacaterol inhalation is used to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, which includes chronic bronchitis and emphysema). Indacaterol is in a class of medications called long-acting beta-agonists (LABAs). It works by relaxing and opening air passages in the lungs, making it easier to breathe.
Indacaterol works by stimulating adrenergic beta-2 receptors in the smooth muscle of the airways. This causes relaxation of the muscle, thereby increasing the diameter of the airways, which become constricted in asthma and COPD. It is also long-acting due to its high affinity to the lipid raft domains in the airway membrane so it slowly dissociates from the receptors.
Mometasone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching. In asthma, mometasone is believed to inhibit mast cells, eosinophils, basophils, and lymphocytes. There is also evidence of inhibition of histamine, leukotrienes, and cytokines.
Mometasone furoate binding to a glucocorticoid receptor causes conformational changes in the receptor, separation from chaperones, and the receptor moves to the nucleus. Once at the nucleus, receptors dimerize and bind to a DNA sequence known as the glucocorticoid response element which either increases the expression of anti-inflammatory molecules or inhibits the expression of pro-inflammatory molecules. Mometasone furoate also reduces inflammation by blocking transcription factors such as activator-protein-1 and nuclear factor kappa B (NF-kappaB).
At the recent SEC for Pulmonary held on 28.04.2022, the expert panel reviewed Glenmark pharmaceuticals proposal to manufacture and market the FDC Indacaterol (as acetate) and Mometasone furoate Dry Powder for Inhalation (DPI) along with the justification of the BA study waiver in detail..
The committee noted that the drug is already approved by Europe, Australia, Canada, and Japan.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the FDC Indacaterol (as acetate) and Mometasone furoate Dry Powder for Inhalation (DPI) in Capsules for the proposed indication subject to the condition that the firm should conduct active post-marketing surveillance for which protocol should be submitted to CDSCO within three months of approval of the drug.
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